The invention relates to an apparatus and a process for testing filters.
Specifically, though not exclusively, the invention can be usefully applied for filters of an apparatus for extracorporeal blood treatment, in particular for membrane filters normally used in a device for on-line preparation of a dialysis liquid and/or a replacement liquid, in the ambit of an apparatus for hemodialysis and/or hemo(dia)filtration, with the aim of removing germs contained in the liquid.
Membrane filters are used in the production of sterile liquids, by causing the liquid to pass through a semi-permeable membrane able to filter the germs. Also known are various processes for checking the characteristics of the membrane of a filter in order to guarantee its efficiency in treating the germs.
One of the known processes is the bubble point test (BPT), which can check on the absence of membrane pores having pores which have a greater size than a predetermined limit. The BPT considers the membrane pores as capillary tubes, and the maximum radius of the pores is determined by pressure measurements. The test briefly comprises the following stages: the membrane is wetted so that the pores are full of liquid; a first side of the membrane is connected to a gas source, while the opposite side is connected to a liquid for easy detection of gas bubbles; the first side of the membrane is gradually pressurised with the gas; while the gas pressure on the first side remains relatively low, a modest amount of gas will displace, by diffusion, through the liquid contained in the membrane pores towards the second side of the membrane; this amount of gas flow is proportional to the speed of increase of gas pressure on the first side; when the gas pressure reaches a certain level, the liquid contained in the largest pores is forced to exit from the pores themselves, and a considerable amount of gas crosses the largest pores, reaching the liquid connected to the second side of the membrane, forming gas bubbles within the liquid; in this situation a further pressuring action leads to a further displacement of gas towards the second side of the membrane, with no discernible increase in pressure; the substantially stable pressure reached in this situation (bubble point pressure, or BP pressure) is a known function of the maximum radius of the membrane pores and thus enables determination thereof; stopping the pressurisation action leads to a situation of substantial equilibrium in the BP pressure.
Prior-art document U.S. Pat. No. 4,614,109 describes a process for checking the permeability of a wet membrane of a filter, based both on a search for the BP pressure and on the determination of the gas diffusion before reaching BP pressure. In this process, the filter membrane is first impregnated with liquid; thereafter, the inlet side of the membrane is gradually pressurised by introduction of a gas; the gas that passes by diffusion through the membrane is collected in a graduated container; the permeability of the membrane is calculated on the basis of the transmembrane pressure measured on the two sides o the membrane, and of the quantity of gas diffused through the membrane per unit of time using the graduated container. By continuing with the pressurisation, at a certain point (called the visual bubble point because it can be visually detected) the production of gas bubbles on the exit side of the membrane sharply increases: this, as mentioned above, is due to the fact that, on reaching the bubble point pressure, the passage of gas through the membrane occurs both by diffusion (in a small part) and (prevalently) by effect of the formation of gas conduits through the pores of the membrane.
U.S. Pat. No. 4,614,109 further describes a process by which the transmembrane pressure can be determined by pressure measurements performed only on the inlet side of the membrane, i.e. on the side which, in the case of a sterile filter, is considered non-sterile, with the aim of not contaminating the sterile side of the membrane by performing these measurements. This is done by measuring a pressure gradient between the inlet side of the membrane and a specific reference pressure system which at the outset of each test is connected to the gas source generating the test pressure.
U.S. Pat. No. 5,064,529 describes an automatic BPT (without the need to observe the moment of gas bubble formation) to check whether the effective BP pressure of the membrane corresponds to the desired BP pressure corresponding to the maximum diameter of the pores indicated by the membrane manufacturer; in a first stage the first side of the membrane is pressurised with the gas at a predetermined constant pressurisation speed, at the end of which first stage the pressure measured on the first side of the membrane should correspond to a predetermined theoretical pressure; the pressurisation speed and the pressurisation time are chosen so that the above-mentioned theoretical pressure is lower than the desired BP pressure; if the pressure measured after the predetermined time does not correspond to the theoretical pressure, a fault is signalled due, probably, to the breakage of the membrane or a faulty installation of the filter; in a second stage, the pressurisation is halted for a certain time period in which the pressure should remain substantially constant; if, on the contrary, there is a significant drop in pressure, a fault is signalled due, probably, to the faulty filling-up of the pores with the liquid; in a third stage, the pressurisation of the first side of the membrane is re-established at a predetermined speed for a predetermined time, during which theoretically the desired BP pressure is reached; if, at the end of the third stage, the desired BP pressure is measured, within a predetermined range of acceptability, it is considered that the maximum diameter of the pores is the desired one.
U.S. Pat. No. 5,594,161 describes a process for testing the integrity of one or more filtering elements in which the inlet side of the filter element is wetted and subjected to a gas pressure which is kept constant, while the pressure is measured on the outlet side which, previously, has been made part of a closed system. If, after a predetermined time, the outlet pressure does not exceed a predetermined threshold value, the filter element is considered intact.
U.S. Pat. No. 6,228,271 describes a process for testing the integrity of filter membranes in which the filter inlet chamber is emptied of liquid and filled with air at atmospheric pressure, while the outlet chamber remains full of liquid. A depression is then created in the outlet chamber in order to create a transmembrane pressure; after the depression has been stabilised, for example at a value comprised between 0.2 and 0.9 bar (absolute pressure), and before completely evacuating the liquid from the outlet chamber, the constant flow of liquid is measured as it exits the outlet chamber, which corresponds to the air flow passing through the perforations of the membrane; the integrity of the membrane is thus measured on the basis of the value measured for the liquid flow.
Another known process for measuring the integrity of a filter membrane is on the basis of a verification modality under sealed pressure, according to which a transmembrane pressure gradient is created and monitored over time in at least one chamber of the filter. A typical sealed pressure test involves, for example, a side of the membrane being brought up to a predetermined gas pressure, below BP pressure, comprised in the diffusion range, i.e. a range in which the pressure in the second membrane chamber increases proportionally to the pressure in the first side; when the pressure has been reached, the gas supply is interrupted and the pressure on the first side monitored; if the drop in pressure per time unit exceeds a predetermined threshold value, the membrane is understood to exhibit some defects.
U.S. Pat. No. 4,702,829 describes a process, of the pressurised sealed type, for verifying the integrity of the filters of a hemodiafiltration apparatus, in which the substitution liquid is realised on-line by passing the dialyser liquid through two sterile filters arranged one after another, each of which exhibits two chambers separated by a water-wettable and semi-permeable membrane, which can hold the germs. The verification process of the filter seal begins after the dialysis circuit washing stage, with the circuit full of the detergent liquid and the water-wettable filter membranes wet. The filter seal verification process uses an ultrafiltration pump, predisposed in the dialysis circuit downstream of the blood treatment device and used in the dialysis treatment for obtaining a patient weight drop measurement. During the filter test, the ultrafiltration pump is used to aspirate air internally of the first chamber of the second filter, through a micro-porous water-repelling filter arranged in a breather of the first chamber. The aspirated air can also enter the second chamber of the first filter in the absence of occlusions in the circuit branch comprised between the two filters. The liquid that leaves space for the aspirated air is removed by the ultrafiltration pump through the membranes of the two filters. Given that the water-wettable membranes of the filters are wet, the membranes themselves are substantially impermeable to air. Therefore, once the second chamber of the first filter and the first chamber of the second filter are entirely occupied by air at atmospheric pressure, and since the air that has entered the chambers cannot escape through the membrane, the ultrafiltration pump can generate a depression in chambers occupied by the liquid, i.e. the first chamber of the first filter and the second chamber of the second filter. The ultrafiltration pump is then activated until a determined depression has been reached in a part of the dialysis circuit filled with liquid. Thereafter, the depression is monitored using a pressure gauge, for example by measuring the time necessary for the pressure to rise by a predetermined quantity, or by measuring the depression after a determined period of time. The monitoring of the depression enables an evaluation of the fluid seal of the system constituted by the membranes and the part of the circuit under depression.
U.S. Pat. No. 4,834,888 describes a control process of the integrity of a sterile filter arranged in the supply system of a dialyser liquid to a dialyser, according to which the dialyser is removed and the flow in the dialyser liquid circuit interrupted, by stopping the circulation pump or alternatively closing two intercept valves, one arranged on the fresh dialyser liquid supply line and the other on the used dialyser liquid drainage line, closing an intercept valve arranged on a rinse line which unites an exit of the first chamber of the sterile filter to the drainage line, opening a ventilation valve arranged in the rinse line between the outlet of the first chamber and the intercept valve, start up the ultrafiltration pump which during the dialysis treatment is used for calculating a patient's weight loss, and finally monitoring the pressure using a pressure gauge arranged on the drainage line. The ultrafiltration pump causes the inlet of air through the ventilation valve and thus inside the first chamber of the sterile filter, while the liquid contained in the first chamber is forced to pass through the membrane and thus internally of the second chamber. When the liquid has been expelled from the first chamber, the wet membrane, if intact, represents an air-impermeable barrier, so that the last action of the ultrafiltration pump causes a depression in the part of the circuit which is connected to the second chamber of the sterile filter; when the pressure gauge signals that a predetermined degree of depression has been reached, the ultrafiltration pump is stopped; if, after a predetermined period of time, the depression has not substantially change, the filter membrane is considered to be intact.
In EP 491981, which concerns a plant for the production of a concentrate for hemodialysis by mixing water with a soluble powder, a test is used for verifying the integrity of a filter which is part of the plant. The plant comprises a gas pump which can be used both for eliminating the gas which is freed during the production of the hemodialysis concentrate in a mixing tank, or for generating, in one of the two chambers of the filter, an overpressure which is monitored to evaluate the integrity of the filter membrane.
U.S. Pat. No. 5,808,181 describes a process for verifying membrane filters arranged in the dialysis circuit of a device for extracorporeal blood treatment, in which the membrane of a filter to be checked is completely wetted with a liquid, a branch of the dialysis circuit containing one of the two filter chambers to be verified is separated from the rest of the circuit, a gas is injected into the separated branch to cause an overpressure, while the liquid contained in the chamber is removed by passing through the membrane; the gas supply is interrupted after a predetermined overpressure level has been reached in chamber; thereafter, the overpressure is controlled, for example by comparing the pressure drop per time unit with a limit value which is characteristic of an intact filter membrane.
EP 407737 describes a process for testing the membrane of a dialyser filter in two stages: in a first stage the blood chamber of the dialyser is subjected to a pressure gradient from the blood chamber to the dialyser fluid chamber; in a second stage the membrane is subjected to an opposite gradient. The test enables a determination of the presence of leaks which might appear or be noted only by effect of one or other of the two pressure gradients.